Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Affiliations
Interests
Timeline
Generic

Timothy Patterson

Osceola,USA

Summary

A veteran clinical compliance expert known for pragmatic problem-solving. Focusing on clinical research including IDE/Pivotal, CE Mark, Post Approval and registries Audit expertise consisting of leading site, vendor and quality systems; BIMO and notified body inspection preparation, support and issue resolution CAPA management and continuous improvement expertise; Subject matter expert on root cause analysis, training and implementation of new regulations; Global project team member supporting SOP harmonization, new standards and business tools; and Mentor and advisor to numerous quality and clinical personnel.

Overview

35
35
years of professional experience
1
1
Certification

Work History

Senior Principal Clinical Quality Specialist- Audit

Corporate Quality
03.2021 - Current
  • Lead internal audit of functions, operating units, clinical Vendors and investigation sites.
  • Coordinate FDA BIMO audit preparation
  • Facilitate training and mentor junior staff
  • Managed large-scale projects from inception to completion, ensuring adherence to budget constraints and timeline requirements.
  • Enhanced company culture by implementing employee engagement initiatives that fostered collaboration, innovation, and professional development.

Principal Clinical Quality Specialist

Medtronic Cardiovascular- Structural Heart and Global Clinical Operations
08.2010 - Current
  • Provided clinical quality/compliance leadership, support and expertise to the Structural heart clinical programs including US IDE, CE Mark and Post Approval Studies
  • Support Quality improvement activities such as CAPAs, audit (internal and external) resolution and training activities
  • Update and maintain SOPs, work instructions as required by Regulation or policy changes
  • Led ad hoc GCP training session on regulation and standards
  • Prepare for and support BIMO inspections

Principal Clinical Quality Specialist

Coronary Structural Heart, Mounds View
08.2010 - 03.2021
  • Primary quality support for the business unit including training, external and internal audit management and vendor oversight.
  • Business lead for FDA BIMO, PMDA and Notified Body sponsor inspections and response coordination.
  • Facilitator of new vendor qualification and compliance gap assessment.

Principal Project Manager

Medtronic IT- Quality, Regulatory and Clinical
06.2009 - 08.2010
  • Team lead of Quality application team consisting of two Project managers and three contract business analysts
  • Technical support of all Global Quality and Regulatory applications
  • Responsible for staffing, resource planning and financial management of compliance applications

Principal Global Initiatives Lead

Medtronic Corporate Quality
01.2006 - 06.2009
  • Managed and successfully deployed a global quality initiative-GCAPA utilizing Sparta TrackWise
  • Led global governance and system support for complaint handling, Field corrections and global product comment technologies
  • Served as compliance expert for department, led CAPA training, regulation interpretation, and audit support.

Principal QA Engineer

Medtronic Gastroenterology/Urology
01.2002 - 01.2006
  • Managed and successfully deployed a global quality initiative-GCAPA utilizing Sparta TrackWise
  • Led quality activities including internal audit management, CAPA and product development of premarket devices through commercial release.
  • Audit coordinator for FDA and notified body inspections.
  • Quality lead for technology and production transfers
  • Supported regulatory submission process for PMAs, PMA supplements, 510(K) products and CE certification/marking

Senior QA Engineer

Medtronic Neurostimulation
01.1999 - 01.2002
  • Supported all quality system functions and led quality activities for Puerto Rican technology transfer activities.

Sr. Sterilization Microbiologist/Engineer/Technician

CRDM(Brady Mfg./Sullivan lake)
01.1990 - 01.1999
  • E-Beam and Gamma validation experience. Investigated Hydrogen peroxide plasma sterilant
  • Performed microbial assays in support of production and sterilization. Installed, validated and deployed automated LAL pyrogenicity test systems

Education

Bachelor of Science - Biology

University of Minnesota- Duluth
Duluth, MN
01-1990

Skills

  • Employee training
  • Organizational management
  • Team collaboration

Accomplishments

Developed the foundation for the organizations BIMO readiness program.

Implemented Global CAPA system and harmonized process

Deployed automation and testing for Microbiology services

Certification

  • Quality Management/Operational Excellence: American Society of Quality, Certification # 8239
  • Quality Auditor: American Society of Quality, Certification # 28316
  • Supplier Quality: American Society of Quality, Certification # 626
  • Lead Auditor Certificate- ISO 13485 (ASQ)
  • Registered Microbiologist: Consumer Products and Quality, American Society for Microbiology, Certification #3136

Affiliations

  • American society of Quality
  • American Society of Microbiology

Interests

running

Bicycling

outdoor activities

Timeline

Senior Principal Clinical Quality Specialist- Audit

Corporate Quality
03.2021 - Current

Principal Clinical Quality Specialist

Medtronic Cardiovascular- Structural Heart and Global Clinical Operations
08.2010 - Current

Principal Clinical Quality Specialist

Coronary Structural Heart, Mounds View
08.2010 - 03.2021

Principal Project Manager

Medtronic IT- Quality, Regulatory and Clinical
06.2009 - 08.2010

Principal Global Initiatives Lead

Medtronic Corporate Quality
01.2006 - 06.2009

Principal QA Engineer

Medtronic Gastroenterology/Urology
01.2002 - 01.2006

Senior QA Engineer

Medtronic Neurostimulation
01.1999 - 01.2002

Sr. Sterilization Microbiologist/Engineer/Technician

CRDM(Brady Mfg./Sullivan lake)
01.1990 - 01.1999

Bachelor of Science - Biology

University of Minnesota- Duluth

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